Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
1998-12-17
2001-02-27
Warden, Sr., Robert J. (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
C422S297000, C422S300000, C206S210000, C206S370000, C206S439000
Reexamination Certificate
active
06193932
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to holding instruments within a sterilization container.
BACKGROUND OF THE INVENTION
Sterilization containers for effecting instrument sterilization are well known in the art. Such containers may comprise a simple perforated box with a removable lid into which instruments are placed and which is then subsequently wrapped in a vapor transmissive, microorganism resistant material such as Central Supply Room (“CSR”) wrap. Alternatively, the container may be sealed and be provided with ports covered with a vapor transmissive, microorganism resistant material. In either event, the prepared container is then placed into a sterilizer whereupon sterilizing gases pass through the container to sterilize the instruments contained therein. After the sterilization is complete, the vapor transmissive, microorganism resistant material prevents the instruments from being recontaminated. Typical sterilizing gases include: steam, hydrogen peroxide, ethylene oxide, chlorine dioxide peracetic acid and combinations thereof A plasma may be induced to enhance the sterilization process. These and other suitable sterilization schemes are well known to those of skill in the art.
Typically, the instruments to be sterilized are medical instruments, and many are quite delicate. To prevent them from being damaged, it is desirable to hold them within the container so that they do not collide with one another. Holders for this also enhance organization and prevent the instruments from covering other instruments to block the sterilizing gases from reaching all instruments.
One popular form of instrument holder comprises a piece of elastomeric material having an aperture which receives the instrument. Typically, the holder is vertically oriented with the instrument and aperture extending horizontally therethrough. Downwardly depending projections on the holder fit into a perforated portion of container to removably attach the holder to the container. Thus the holders can be arranged to accommodate varying instruments. The aperture in the holder typically intersects an upper edge of the holder creating a notch in the holder so that the instruments, especially long cylindrical instruments, can be inserted downwardly into the aperture and need not be threaded horizontally through the aperture.
One limitation of such systems is the high contact area between the instrument and the holder. To provide some rigidity to the holder, it is usually a thick panel of elastomer. If the aperture is a straight bore throughout the panel it creates a large inner surface to the aperture which contacts a correspondingly large surface of the instrument. Areas of contact between the instrument and holder may not receive sufficient sterilizing gas for complete sterilization. An alternative is to use a sheet metal panel in place of the panel or a wire like wrap which encircles the instrument. In the former, metal may cause damage to delicate instruments and since it is not elastomeric, it will not provide the elastomeric holding capability of the elastomeric holder. The wire like wraps require extra manipulation to encircle the instrument.
SUMMARY OF THE INVENTION
The present invention overcomes these and other limitations of the prior art by providing a sterilization container having an improved instrument holder. The sterilization container may take any form known by those of skill in the art but preferably comprises an enclosure having a perforated surface within with the instrument holder affixed to the surface. The instrument holder comprises a panel having at least one projection extending into a perforation through the surface to hold the panel to the perforated surface. An aperture through the panel is adapted to receive an instrument therethrough. The inner surface of the aperture is reduced in area to reduce contact between the instrument and the holder.
The area of contact may be reduced by chamfering the surface to produce a ridge which contacts the instrument. Preferably the ridge is sharp but may instead comprise a narrow radius curve. The instrument holder is preferably formed of a silicone elastomer. A slot may be provided from an upper surface of the holder into the aperture so that the instrument may be inserted radially into the aperture through the slot. Preferably, the slot has a narrower width than a diameter of the aperture whereby an instrument inserted therein may be retained more securely. The contact area may be further reduced by roughening the contact surface, preferably by structural texturing in a specific pattern, such as by providing a plurality of small protuberances within the aperture.
A method for sterilizing a surgical instrument according to the present invention comprises enclosing the instrument within a sterilization container which comprises an enclosure having an instrument holder therein. The instrument holder comprises a panel having at least one aperture therethrough. The aperture extends between first face second faces of the panel and is defined by an inner aperture surface between these two faces. The instrument is placed into the aperture into contact with the inner aperture surface and a sterilizing gas is admitted into the enclosure. The inner aperture surface is shaped to minimize contact with the instrument in the aperture and a portion of the instrument within the aperture between the first and second faces is contacted with the sterilizing gas.
Preferably, at least 40 percent of that portion of the instrument disposed within the aperture between the first and second faces is out of contact with the inner aperture surface and is contacted with the sterilizing gas in the contacting step, more preferably this percentage is at least 80 percent and most preferably at least 95 percent.
REFERENCES:
patent: 4262799 (1981-04-01), Perrett
patent: 5441709 (1995-08-01), Berry, Jr.
patent: 5492671 (1996-02-01), Krafft
patent: 5552115 (1996-09-01), Malchesky
patent: 5628970 (1997-05-01), Basile et al.
patent: 5843387 (1998-12-01), Dane et al.
Bankert Charles S.
Gamsarian Anahid
Merhazion Abraham
Wu Su-Syin
Ethicon Inc.
Farmer Andrew C.
Snider Theresa T.
Warden, Sr. Robert J.
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